对所有临床文本文件进行认证的非识别系统,以在规模上提取信息
Lakshmi Radhakrishnan1, Gundolf Schenk2, Kathleen Muenzen2
1Academic Research Services, Information Technology, University of California, San Francisco, San Francisco, California, USA.
JAMIA open
|July 7, 2023
概括
这项研究开发了一种经过认证的管道来消除临床笔记的识别,使超过1.3亿条记录可供研究人员在没有额外的伦理审查的情况下使用. 菲尔特软件确保了可访问的患者数据的HIPAA合规性.
科学领域:
- 医疗信息学 医疗信息学
- 医疗数据安全 医疗数据安全
- 临床研究 临床研究
背景情况:
- 临床笔记包含有价值的患者信息,但由于隐私问题而受到限制.
- 访问临床数据进行研究往往需要广泛的伦理审查和机构审查委员会 (IRB) 的批准.
- 保护健康信息 (PHI) 的非识别可以简化研究访问.
研究的目的:
- 开发一个强大的和可扩展的临床文本非识别管道,符合HIPAA标准.
- 与研究界分享常规更新的非标识性临床笔记.
- 减少对使用临床笔记的研究人员进行额外的IRB审查的需要.
主要方法:
- 改进了开源的Philter软件,以实现HIPAA合规性和认证的身份删除.
- 实现了功能,以减少过度删除和正常化/变更日期PHI.
- 使用MongoDB建立了一条精简的管道,用于自动提取和每月刷新被删除标识的笔记.
主要成果:
- 菲尔特V1.0管道是第一个经过认证的临床笔记非识别系统,可以在没有进一步IRB批准的情况下进行研究.
- 已向600多名研究人员提供了超过1.3亿份经认证的非身份化临床笔记.
- 数据跨越40年,包括超过270万患者的记录.
结论:
- 开发的管道成功提供了一种经过认证,符合HIPAA标准的方法,用于消除临床笔记的识别.
- 这有助于更广泛地获取有价值的临床数据用于研究目的.
- 该系统支持通过自动化,定期更新与研究人员持续共享数据.
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